Cannula Clamp
FDA 510(k) K853538 · Cp Medical
510(k) numberK853538
Submission
- Device name
- Cannula Clamp
- Applicant
- Cp Medical
Costa Mesa, CA, US - Received
- August 23, 1985
- Decision date
- September 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXD – Clamp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890381 | Parametrium ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890372 | Intestinal ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890371 | Intestinal Crushing ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890368 | Kidney ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K874959 | Vascular ClampHXD · Traditional | Solway, Inc. | 12/30/1987SE |
| K872386 | C ClampHXD · Traditional | Med-Tool, Inc. | 07/02/1987SE |
| K863653 | Suction-OffHXD · Traditional | B&B Medical Technologies, Inc. | 10/07/1986SE |
| K851654 | Omnimed ClampHXD · Traditional | Omni Intl., Inc. | 05/31/1985SE |
| K801819 | Surgical InstrumentsHXD · Traditional | Robert I. Chien & Assoc., Inc. | 08/20/1980SE |
| K801028 | Rica or Smic Surgical InstrumentsHXD · Traditional | Robert I. Chien & Assoc., Inc. | 05/20/1980SE |
More from Robert I. Chien & Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173922 | C-PTFETM Surgical SutureNBY · Traditional | 03/26/2018SE |
| K094028 | Cp-Fiber (Orthofiber)GAT · Abbreviated | 03/18/2010SE |
| K072229 | MonoswiftGAM · Abbreviated | 10/05/2007SE |
| K071550 | Pre-Waxed Needles with Gold Fiduciary MarkersKXK · Abbreviated | 07/18/2007SE |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31MTJ · Traditional | 11/02/2006SE |
| K041894 | OrthofiberGAT · Special | 09/17/2004SE |
| K034062 | CP Sleeve and River SleeveKXK · Special | 01/30/2004SE |
| K024372 | CP Medical Bone WaxMTJ · Traditional | 06/19/2003SE |
| K030786 | Mono-SwiftNEW · Abbreviated | 05/06/2003SE |
| K030351 | Stainless Steel Surgical Suture, Non-AbsorbableGAQ · Abbreviated | 03/28/2003SE |
Questions and answers
When was Cannula Clamp cleared by the FDA?
Cannula Clamp (K853538) received a 510(k) decision of Substantially Equivalent on September 12, 1985, 20 days after the submission was received.
What is the product code of K853538?
The FDA product code is HXD – Clamp, a Class I (low risk) device regulated under 21 CFR 878.4800.